Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04541004
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2020-09-01
Brief Title:
Adolescent Mite Allergy Safety Evaluation
Sponsor:
ALK-Abelló AS
Organization:
ALK-Abelló AS
Study Overview
Official Title:
A 28-day Single-armed Open-label Trial to Evaluate Safety of the House Dust Mite HDM Sublingual Allergy Immunotherapy SLIT Tablet in Adolescent Subjects With HDM Allergic RhinitisRhinoconjunctivitis With or Without Asthma
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMASE
Brief Summary:
This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitisrhinoconjunctivitis
The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies when used to treat adolescents who have these allergies
The trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents 12-17 years old in several countries
The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies when used to treat adolescents who have these allergies
The trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents 12-17 years old in several countries
Detailed Description:
This trial is a 28-day single-arm open-label phase III trial to evaluate safety of the house dust mite SLIT-tablet in adolescents 12-17 years of age with HDM allergic rhinitisrhinoconjunctivitis with or without asthma Approximately 250 adolescents will be enrolled in the trial and will receive the house dust mite SLIT tablet The trial is conducted in several European countries
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-000446-34 | EUDRACT_NUMBER | None | None |